Learn the requirements of ISO 13485:2016 while understanding how they relate to your organization.

This ISO 13485 Internal Auditor Training addresses how management systems (MS) conforming to ISO 13485 apply to the medical device industry and how to develop a management system that conforms for ISO 13485 certification.

This ISO 13485 Internal Auditor Training is intended particularly for companies that produce or service medical devices or are part of an FDA regulated industry. It addresses the concerns specific to the medical device industry including risk management, software validation and supplier management.

  • Interpret and apply the requirements of ISO 13485:2016
  • Apply ISO 14971:2007
  • Use the QMS and ISO 13485 to ensure compliance to applicable regulations
  • Implement regulatory issues with minimal impact upon operations
  • Identify and implement the controls necessary for ensuring the QMS consistently meets requirements
  • Develop reliable and pliable systems, particularly effective for organizations where process objectives are constantly changing
  • Determine and communicate the resources necessary for the system to work as planned
  • Communicate the roles and responsibilities within the QMS to the organization
  • Relate the capabilities of the organization to the expectations of customers, top management and shareholders
  • Use the QMS to work proactively and not reactively, manage risk, validate software and manage suppliers
  • Medical device professionals
  • Professionals from FDA regulated industries
  • Quality professionals
  • ISO Managers/Management Reps
  • Internal Auditors
  • Process owners
  • Systems professionals or people who want to understand how management systems work
  • Improvement Specialists
  • Buyers in FDA regulated industries
  • Leaders/managers/professionals in the Medical Device industry

This class may be run in conjunction with a ISO 13485 Lead Auditor Training Course.

DAY 1

  • Lecture: Intro to Management Systems
  • Lecture: Internal Audit
  • Lecture: Internal Audit Planning and Preparation
  • Workshop: ISO 13485 – Review System Docs and Prep Audit Schedule
  • Workshop: ISO 13485 – Reviewing Processes and Prep Checklists

DAY 2

  • Lecture: ISO 13485
  • Test: ISO 13485 Self Study
  • Lecture: Performing the Internal Audit Investigation
  • Workshop: ISO 13485 – Determining Nonconformities
  • Lecture: Concluding the Audit

DAY 3

  • Lecture: Corrective Action and Follow-up
  • Workshop: Writing Nonconformity Statements
  • Workshop: ISO 13485 – Interviewing Auditees

Students successfully completing QMII’s 3-day ISO 13485 Internal Auditor training course and the TPECS examinations provided in conjunction with this course, receive a Certificate of Attainment for the following Exemplar Global (formerly RABQSA International) knowledge competency units:

MD – Medical Devices Management Systems

AU – Management Systems Auditing

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global in the competency units required for certification as a Medical Devices Management Systems Internal Auditor using ISO 13485:2016.

Successful course candidates can use these certifications as earned credit towards other certifications such as ISO 9001, ISO 14001 Auditor and other similar standards under Exemplar Global’s Training Provider & Examiner Certification Scheme (TPECS).